Question 1

What types of medical devices does Etablissements Oury Guyé et Fils manufacture?

Accepted Answer

Etablissements Oury Guyé et Fils specialises in reusable orthopaedic surgical instruments. Their portfolio includes general internal orthopaedic fixation system implantation kits, self-retaining and hand-held retractors, retraction system mounting frames, bone hooks, implant inserters/extractors, and manual bone files/rasps and curettes. These tools are designed to assist in orthopaedic procedures such as bone preparation, retraction, and implant placement.

Question 2

Where is Etablissements Oury Guyé et Fils based?

Accepted Answer

The company is based in France. This European location allows them to comply with EU regulatory requirements, including device listing in the EU’s EUDAQS database (eudamed).

Question 3

Which regulatory registries list devices manufactured by Etablissements Oury Guyé et Fils?

Accepted Answer

Devices from Etablissements Oury Guyé et Fils are listed in the EU’s EUDAQS database (eudamed) and the FDA’s Unique Device Identifier (UDI) system (fda_udi). Listing in these registries helps ensure traceability and compliance with regulatory requirements in both the European Union and the United States.

Question 4

How are the devices produced by Etablissements Oury Guyé et Fils classified?

Accepted Answer

All devices produced by Etablissements Oury Guyé et Fils fall under Class I classification. Class I devices are generally considered low-risk, often involving general-purpose surgical instruments or accessories that do not present significant health risks when used as intended. This classification simplifies regulatory oversight while maintaining compliance with safety standards.

Device	Model / Reference	Registries	Class	Status
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye Et Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Oury-Guye & Fils	A	FDA UDI	Class I	Active
Cintreuse De Stagnara	D11076M	EUDAMED	Class I	Active
Plate Minicut 1.6 Mm	D11269M	EUDAMED	Class I	Active
Cintreuse A Barillet Reglable	D11077M	EUDAMED	Class I	Active
Ouvre Bouche De Delabarre	K11770M	EUDAMED	Class I	Active
Wavy French Bender	D11533M	EUDAMED	Class I	Active
Pike Plier	D11529M	EUDAMED	Class I	Active
Spatules De Teissier 315 Mm "brevete"	B10578M	EUDAMED	Class I	Active
Robinson Plate Bender 21 Cm Copyright	D11303M	EUDAMED	Class I	Active
Mini Plate Plier	D11526M	EUDAMED	Class I	Active
Pince A Dilater Les Tubes	A10492M	EUDAMED	Class I	Active
French Bender	D11079M	EUDAMEDFDA UDI	Class I	Active
Jeu De Spatules Obstetriques 36 Cm	B10573M	EUDAMED	Class I	Active
Epingle Porte-Instruments 12 Cm	A10407M	EUDAMED	Class I	Active
Pince Coupe Broche 2.5 Mm Arex Og 21 Cm Modele Depose	D11302M	EUDAMED	Class I	Active
Rod Cutter Adap-Table	D11253M	EUDAMED	Class I	Active
Suppor Table	D11252M	EUDAMED	Class I	Active
Epingle Porte-Instruments 18cm	A10408M	EUDAMED	Class I	Active
Quick Cutter	D11530M	EUDAMED	Class I	Active
Ouvre-Bouche De Doyen Nourisson	ZK1775	EUDAMED	Class I	Active
Pince 3 Points	D11388M	EUDAMED	Class I	Active
Pince A Traire Les Drains Gunnar Hey 20 Mm	A10377M	EUDAMED	Class I	Active
Mini Cintreuse Avec Galet Central Ø17 Pour Tige Ø5.5	D11078M	EUDAMED	Class I	Active
MARTEAU DE JUDET 1000 g	ZD1437M	EUDAMEDFDA UDI	Class I	Active
SIMPLE SMALL BENDER 180mm	D11298M	EUDAMED	Class I	Active
Ouvre Bouche De Doyen Adulte	K11765M	EUDAMED	Class I	Active
Presse A Cotyle Esic Modele Depose	D11412M	EUDAMEDFDA UDI	Class I	Active
Pince Presse-Tube De Murphy 18 Cm B/P	A10373M	EUDAMED	Class I	Active
Pince Minicut 1.6 Modele Depose	D11414M	EUDAMED	Class I	Active
Plate Multinox	D11528M	EUDAMED	Class I	Active
SPATULES DE TEISSIER longues 37CM	ZB0575M	EUDAMED	Class I	Active

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